Welcome to this week’s installation of Warning Letter of the Week (WLOTW). This week, we will be the last article in our series on a Warning Letter issued to Olympus Medical Systems (full Warning Letter).
So far, we’ve dived into issues relating to Olympus Medical not properly handling data, not performing re-validation on sterilization processes, and not having a proper complaint handling process. Check out Part One and Part Two here, for more context on those issues.
Also, if you want to learn more about Warning Letters, check out FDA Warning Letters: Everything You Need to Know.
If you’ve been following along, it’s easy to guess what other processes Olympus was struggling with at the time of the Warning Letter. That’s why in this article, we’re reviewing everything related to Olympus Medical’s Medical Device Reporting (MDR) procedure.
Table of Contents
Failure to Maintain MDR Procedure
The first finding we’ll be discussing today is about Olympus Medical’s failure to “adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17(a).“
This is a trend throughout the Warning Letter and is closely related to the findings we’ve discussed in the previous posts.
The Warning Letter does provide a lot of specifics that should help you if you are ever implementing or updating an MDR procedure for your company.
For example, one of the findings had to do with which definitions were listed in Olympus’ Medical Device Reporting Work Instruction:
The procedure includes definitions from 21 CFR 803.3 for the terms “become aware”, “malfunction”, “MDR reportable event”, and the definition of the term “reasonably suggest” found in 803.20(c)(1). However, the procedure omits definitions of the terms “caused or contributed” and “serious injury” from the 21 CFR Part 803.3. The exclusion of the definitions for those terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
Here, we can see that the FDA is practically telling you to copy over all of the definitions listed in 21 CFR Part 803.3. There is no need to be creative at this point when creating an MDR procedure, just copy all of the applicable definitions.
The finding continues from there, listing the different items that were not present in Olympus Medical’s MDR procedure:
- no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event.“The “MDR Decision Tree” does not include a specific process for investigating MDR events, and ensuring they are submitted within the required timeframe.
- (No) Instructions for how to obtain and complete the FDA 3500A form.
- How your firm will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow-up within the firm.
The main goal of the WLOTW articles is to help regulatory and Quality Assurance professionals learn from the mistakes of other companies and help their companies avoid those mistakes. While the information on MDRs is not the most interesting to many people, learning the specifics about what the FDA is requesting can be very useful.
The FDA does not come out and say things like “You must write a process that states where to obtain FDA 3500A Form”. However, we can see that this is what is expected from a medical device company.
Many people create extremely bare-bones MDR procedures. They just cover the basics of, “We’ll receive a complaint and follow our complaint handling procedure, then determine if we need to report the complaint, and follow up with our CAPA actions”.
This is something that is not an issue until it is a major issue. If you at some point do not report a complaint correctly or within the proper timeframe, there can be serious consequences. That is why it is important to receive Warning Letters straight from the FDA’s mouth.
Another thing to note is that Olympus did not provide a response to this finding, since it was not listed in the initial form 483 given to the company.
Failure to Submit a Complaint within 30 Days
The next finding is also something we’ve covered in previous posts on this Warning Letter, so we won’t go into too much detail here. In short, Olympus Medical received a complaint that a product malfunctioned during use, which led to potential “mucosal tissue damage“.
Olympus did not report the complaint, which could potentially lead to serious injury or death, within the FDAs time frame of 30 days.
Olympus did perform a recall due to the malfunction and opened a large number of MDRs related to the events surrounding the initial injury. However, these MDRs were not received by the FDA within the required time frame.
This is further evidence of how seriously the FDA treats MDR events, which makes sense in context. These are events that could lead to a life-altering injury to a patient, and medical device companies have every responsibility to properly handle related complaints.
On a side note, after seeing the Warning Letter, I realized I had been contacted by a recruiter for a position with Olympus as an MDR Submission Analyst in June of 2022. I could have only imagined the bomb I would be walking into at that time if I had considered that role. But, at least they realized this was a real need.
Follow-up on not Submitting a Complaint
The follow-up to this finding references many of the corrective actions listed earlier in the Warning Letter.
They performed a retrospective review of complaints related to part MAJ-2315m and identified 98 complaints that needed to be evaluated for reportability. They also updated their complaint handling procedure. However, they have not shown the FDA sufficient evidence that all of the corrective actions have been completed.
Lessons Learned
There will not be a long Lessons Learned section this week, as most of the specific lessons can be found in the MDR section. However, feel free to review the lessons from the previous posts as a reminder of how to avoid this issue.
Wrapping Up
That was the final post in our multi-part series on the Warning Letter issued to Olympus Medical. If you enjoyed these posts, make sure to follow our newsletter to be kept up to date with everything happening in the world of Medical Devices and Warning Letters.
As always, if you have any questions or thoughts on this Warning Letter, feel free to leave them in the comments below.